- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT04325555
Pre-exposure Prophylaxis: A Miracle Drug or a Moral Hazard
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
-
-
-
Abu Dhabi, Zjednoczone Emiraty Arabskie, 00000
- New York University Abu Dhabi
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- 18 years or above
- living in the London, New York, Toronto or Sydney metro area
- self-reported sex at birth is male
- reported ever having sex with a male
Exclusion Criteria:
- not meeting the inclusion criteria
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
Respondents on PrEP
On PrEP status will be operationalized in multiple ways, and sensitivity analyses will be conducted using multiple definitions as a result of the self-reported nature of the study.
A comparison group will be constructed by matching on a variety of characteristics, when this method is applied. Most importantly, age, and STD testing frequency among others, which influence the likelihood of being on PrEP and via that avenue sexual practices, as well as the likelihood of detecting STDs (i.e., ascertainment bias). In other models adjustments will be made for these factors. |
The investigators measure self-reported PrEP status as exposure, i.e., PrEP status is not confirmed via matched medical records or any other type of information directly collected form subjects.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Syphilis diagnosis
Ramy czasowe: All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
|
Self-reported diagnosis of syphilis
|
All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
|
|
Chlamydia diagnosis
Ramy czasowe: All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
|
Self-reported diagnosis of chlamydia
|
All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
|
|
Gonorrhea diagnosis
Ramy czasowe: All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
|
Self-reported diagnosis of gonorrhea
|
All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
|
|
Sexually transmitted diseases
Ramy czasowe: All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
|
Self-reported diagnosis of any STD
|
All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
|
|
Percent of time that condoms were used in sexual intercourse
Ramy czasowe: 12 months
|
Self-reported condom adherence
|
12 months
|
|
Number of ongoing sexual relationships
Ramy czasowe: Through study completion, approximately 2 months
|
Self-reported number of concurrent sexual partners
|
Through study completion, approximately 2 months
|
|
Number of sexual partners over the past 12 months
Ramy czasowe: 12 months
|
Self-reported number of sexual partners over the past 12 months
|
12 months
|
|
Selecting a potential date with many recent partners
Ramy czasowe: Through study completion, approximately 2 months
|
The likelihood of selecting a potential date with 6 or more recent sexual partners in the conjoint experiment. Both AMCEs (average marginal component effects) and marginal means will be computed, see statistical analysis plan. As part of a conjoint experiment the investigators expose participants to a partner selection task. The attributes in the experiment and possible attribute values can be seen below: Race/ethnicity: White/Black/Asian Education: High school/Undergraduate degree/Graduate degree Number of sexual partners (past 3 months): 1/2-5 partners/6 or more Recreational drug use: Never/Sometimes/Often Seeking a...: Committed relationship/Casual relationship Use of condoms: Occasional/Frequent |
Through study completion, approximately 2 months
|
|
Selecting a potential date with frequent recreational drug use
Ramy czasowe: Through study completion, approximately 2 months
|
The likelihood of selecting a potential date with frequent recreational drug use in the conjoint experiment. Both AMCEs (average marginal component effects) and marginal means will be computed, see statistical analysis plan. As part of a conjoint experiment the investigators expose participants to a partner selection task. The attributes in the experiment and possible attribute values can be seen below: Race/ethnicity: White/Black/Asian Education: High school/Undergraduate degree/Graduate degree Number of sexual partners (past 3 months): 1/2-5 partners/6 or more Recreational drug use: Never/Sometimes/Often Seeking a...: Committed relationship/Casual relationship Use of condoms: Occasional/Frequent |
Through study completion, approximately 2 months
|
|
Selecting a potential date with occasional condom adherence
Ramy czasowe: Through study completion, approximately 2 months
|
The likelihood of selecting a potential date with occasional condom use in the conjoint experiment. Both AMCEs (average marginal component effects) and marginal means will be computed, see statistical analysis plan. As part of a conjoint experiment the investigators expose participants to a partner selection task. The attributes in the experiment and possible attribute values can be seen below: Race/ethnicity: White/Black/Asian Education: High school/Undergraduate degree/Graduate degree Number of sexual partners (past 3 months): 1/2-5 partners/6 or more Recreational drug use: Never/Sometimes/Often Seeking a...: Committed relationship/Casual relationship Use of condoms: Occasional/Frequent |
Through study completion, approximately 2 months
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
The likelihood at which a respondent would engage a partner in casual sex with without using condoms
Ramy czasowe: Through study completion, approximately 2 months
|
This is collected as a follow-up question for each profile in the conjoint experiment as detailed above
|
Through study completion, approximately 2 months
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Kinga R Makovi, PhD, New York University Abu Dhabi
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Procesy patologiczne
- Infekcje
- Choroby zakaźne
- Atrybuty choroby
- Zakażenia bakteriami Gram-ujemnymi
- Infekcje bakteryjne
- Infekcje bakteryjne i grzybice
- Zakażenia Neisseriaceae
- Choroby przenoszone drogą płciową, bakteryjne
- Infekcje Spirochaetales
- Infekcje krętkowe
- Rzeżączka
- Choroby przenoszone drogą płciową
- Syfilis
Inne numery identyfikacyjne badania
- 097-2018
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .